The concern for me does not lie in NanoDX's ability to achieve an EUA, but rather the US downgrading the situation from a "public health emergency" thus closing the door. Of course, we are still far from this occurring but the US has rolled out the vaccine fairly successfully in my opinion and eventually the day will come. Also, regardless of the EUA, NanoDX will push through the standard FDA regulatory process but this is not expedited like the EUA.
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-during-covid-19-pandemic
